The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants

Inclusion Criteria:

• Aged 30 to 65 years inclusive at the time of signing informed consent
• Must agree to adhere to the contraception requirements. In addition, vasectomised male participants with partners of childbearing potential must have received medical assessment of the surgical success of the procedure Healthy male participants according to the assessment of the Investigator, as based on a complete medical history including a physical examination, vital signs, single 12-lead ECGs, and laboratory safety tests without any clinically significant abnormalities as measured at screening. ECGs and vital signs to be re-checked at pre-dose.
• Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening.
• Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day).

Exclusion Criteria:

• Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator. Hay fever is allowed unless it is active.
• History of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory, particularly GI disease, especially peptic ulceration, clinically significant GI bleeding, UC, CD, Irritable Bowel Syndrome or malabsorption syndrome that may impair bioavailability, and neurological or psychiatric disorder
• Participants who are unable to take oral medication.
• Acute diarrhea, constipation or vomiting in the 7 days before the predicted Day 1. If screening occurs >7 days before Day 1his criterion will be determined on Day 1. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than three times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day